Viaskin Peanut for Peanut Allergy

(VITESSE Trial)

Recruiting at 88 trial locations

Overseen By DBV Technologies

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: DBV Technologies

Must not be taking: Immunotherapy, Biologics

Disqualifiers: Severe dermatologic disease, Uncontrolled asthma, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 12 months

600 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary purpose of this study is to assess the efficacy and safety of daily DBV712 250 micrograms (mcg) to induce desensitization to peanut in peanut-allergic children 4-7 years of age over a 12-month double-blind, placebo-controlled (DBPC) Treatment Period.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently on immunotherapy for any allergen or have used certain treatments like monoclonal antibodies within 6 months before the trial.

What data supports the effectiveness of the treatment Viaskin Peanut for peanut allergy?

Research shows that Viaskin Peanut, a patch containing peanut protein, is more effective than a placebo in helping children with peanut allergies become less sensitive to peanuts. This means that children using the patch can tolerate more peanuts without having an allergic reaction. ^{1 2 3 4 5}

Is Viaskin Peanut safe for people with peanut allergies?

Viaskin Peanut, used in epicutaneous immunotherapy (a treatment applied to the skin), has been well tolerated in clinical trials for peanut-allergic children, showing it is generally safe for use in humans. ^{1 3 4 6 7}

How is the Viaskin Peanut treatment different from other peanut allergy treatments?

Viaskin Peanut is unique because it uses a patch to deliver small amounts of peanut protein through the skin, which helps desensitize the immune system to peanuts. This method, known as epicutaneous immunotherapy, is different from other treatments that might involve oral ingestion or avoidance strategies. ^{1 3 4 7 8}

Eligibility Criteria

This trial is for peanut-allergic children aged 4-7 who react to a very small amount of peanut protein and are on a strict peanut-free diet. They must have certain levels of peanut-specific antibodies and skin test reactions. Kids with uncontrolled asthma, past immunotherapy for peanuts, or recent biologic treatments can't join.

Inclusion Criteria

Peanut-specific IgE of >0.7 kilo allergy unit per liter (kUA/L) and a positive peanut SPT with the largest wheal diameter of ≥6 millimeter (mm) at Visit 1

Physician-diagnosed peanut allergy or children with a well-documented medical history of IgE-mediated reactions after ingestion of peanut and currently following a strict peanut-free diet

I am between 4 and 7 years old.

Exclusion Criteria

I have severe skin disease on my upper back.

My asthma symptoms are not well-controlled.

I have received or am receiving immunotherapy for peanut allergy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

2 visits (in-person)

Treatment

Participants receive daily DBV712 250 mcg or placebo for 12 months to assess efficacy and safety in inducing desensitization to peanut

12 months

Monthly visits (in-person)

Open-label Extension

Participants apply DBV712 250 mcg daily for an additional 24 or 36 months, depending on initial randomization, to continue treatment and assess sustained unresponsiveness

24-36 months

Annual visits (in-person)

Follow-up

Participants are monitored for sustained unresponsiveness through open food challenges at 2, 4, and 6 months off treatment

6 months

3 visits (in-person)

Treatment Details

Interventions

• DBV712
• Placebo

Trial Overview The study tests the safety and effectiveness of DBV712 (250 mcg), a daily treatment aimed at desensitizing children to peanuts over one year. The comparison is made against a placebo—a substance with no active drug—to see if DBV712 makes any difference.

Participant Groups

Group I: Open Label Extension Period: DBV712 250 mcg Experimental Treatment 1 Intervention

Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 2 additional years if they were randomized DBV712 250 mcg or for 3 years if they were randomized placebo. After 12 months of open-label treatment with DBV712 250 mcg, (i.e., at the end of Month 24), participants will undergo a peanut DBPCFC according to the following schedule: 3, 10, 30, 100, 300, 600, 1000, and 2000 mg (4043 mg cumulative dose). Participants who were randomized to placebo will also undergo an additional peanut DBPCFC after 24 months of open-label treatment with DBV712 250 mcg, (i.e., at the end of Month 36).

Group II: DBPC Treatment Period: DBV712 250 mcg Experimental Treatment 1 Intervention

Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 12 months. At Month 12, a post-treatment peanut DBPCFC will be performed, with a starting dose of 3 mg peanut protein with escalation to the highest dose of 1,000 mg peanut protein according to the following schedule: 3, 10, 30, 100, 300, 600, and 1,000 mg (2,043 mg cumulative dose).

Group III: DBPC Treatment Period: Placebo Placebo Group 1 Intervention

Participants will apply DBV712 matching placebo epicutaneous system (or patch), daily for a period of 12 months. At Month 12, a post-treatment peanut DBPCFC will be performed, with a starting dose of 3 mg peanut protein with escalation to the highest dose of 1,000 mg peanut protein according to the following schedule: 3, 10, 30, 100, 300, 600, and 1,000 mg (2,043 mg cumulative dose).

Who Is Running the Clinical Trial?

DBV Technologies

Lead Sponsor

Trials

17

Recruited

3,500+

References

1. Denmark pubmed.ncbi.nlm.nih.gov

Immune response evolution in peanut epicutaneous immunotherapy for peanut-allergic children. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Treatment of peanut allergy with rush immunotherapy. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children: REALISE Randomized Clinical Trial Results. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Epicutaneous immunotherapy for the treatment of peanut allergy in children and young adults. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Assessing the efficacy of oral immunotherapy for the desensitisation of peanut allergy in children (STOP II): a phase 2 randomised controlled trial: a critical appraisal. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Allergy to peanut oil--clinically relevant? [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of peanut epicutaneous immunotherapy in patients with atopic comorbidities. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Targeted allergen-specific immunotherapy within the skin improves allergen delivery to induce desensitization to peanut. [2023]